The following data is part of a premarket notification filed by Magly Orthopedics, Llc with the FDA for Apex Intramedullary Nail System.
| Device ID | K020562 |
| 510k Number | K020562 |
| Device Name: | APEX INTRAMEDULLARY NAIL SYSTEM |
| Classification | Rod, Fixation, Intramedullary And Accessories |
| Applicant | MAGLY ORTHOPEDICS, LLC 15009 NE 195TH ST. Woodinville, WA 98072 |
| Contact | Dave Stinson |
| Correspondent | Dave Stinson MAGLY ORTHOPEDICS, LLC 15009 NE 195TH ST. Woodinville, WA 98072 |
| Product Code | HSB |
| CFR Regulation Number | 888.3020 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-02-20 |
| Decision Date | 2002-05-16 |
| Summary: | summary |